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New Drug Application (NDA): 020702
Company: UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIPITOR ATORVASTATIN CALCIUM EQ 10MG BASE TABLET;ORAL Prescription AB Yes No
LIPITOR ATORVASTATIN CALCIUM EQ 20MG BASE TABLET;ORAL Prescription AB Yes No
LIPITOR ATORVASTATIN CALCIUM EQ 40MG BASE TABLET;ORAL Prescription AB Yes No
LIPITOR ATORVASTATIN CALCIUM EQ 80MG BASE TABLET;ORAL Prescription AB Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/07/2022 SUPPL-79 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020702Orig1s079correctedlbl.pdf
11/16/2020 SUPPL-77 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020702s077lbl.pdf
09/25/2020 SUPPL-78 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020702s078lbl.pdf
11/27/2019 SUPPL-74 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020702s074lbl.pdf
04/12/2019 SUPPL-73 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020702s073lbl.pdf
08/10/2018 SUPPL-71 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020702s071lbl.pdf
06/23/2017 SUPPL-69 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020702s067s069lbl.pdf
06/23/2017 SUPPL-67 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020702s067s069lbl.pdf
03/11/2015 SUPPL-65 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020702s065lbl.pdf
05/21/2014 SUPPL-64 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020702s064lbl.pdf
10/31/2012 SUPPL-63 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020702s062s063lbl.pdf
10/31/2012 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020702s062s063lbl.pdf
02/28/2012 SUPPL-60 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020702Orig1s060lbl.pdf
06/17/2009 SUPPL-56 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020702s056lbl.pdf
03/27/2009 SUPPL-57 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020702s057lbl.pdf
09/26/2007 SUPPL-50 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020702s050lbl.pdf
03/02/2007 SUPPL-47 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020702s047lbl.pdf
01/16/2007 SUPPL-49 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020702s049lbl.pdf
08/07/2006 SUPPL-44 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020702s044lbl.pdf
09/21/2005 SUPPL-42 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020702s042lbl.pdf
09/29/2003 SUPPL-37 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20702scs037_lipitor_lbl.pdf
05/12/2003 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20702slr036_lipitor_lbl.pdf
10/18/2002 SUPPL-33 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20702s33lbl.pdf
04/22/2002 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20702s29s34lbl.pdf
04/22/2002 SUPPL-29 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20702s29s34lbl.pdf
06/08/2001 SUPPL-25 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20702s25lbl.pdf
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